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A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients

NCT ID: NCT00002190

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Brief Summary

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To explore the antiviral efficacy, tolerability and safety of saquinavir plus zidovudine plus lamivudine.

Detailed Description

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A total of 30 patients receive the triple drug regimen saquinavir plus zidovudine plus lamivudine until the completion of the analysis after at least 4 weeks of therapy.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Saquinavir

Intervention Type DRUG

Lamivudine

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* HIV antibody positive.
* CD4 count \>= 150 and \<= 500 cells/mm3.

Exclusion Criteria

Prior Medication:

Excluded:

* Prior antiretroviral therapy.
* Prior protease inhibitor therapy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Locations

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Davies Med Ctr / c/o HIV Institute

San Francisco, California, United States

Site Status

Pacific Oaks Med Group / Rsch & Scientific Investigation

Sherman Oaks, California, United States

Site Status

Columbia Presbyterian Med Ctr

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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NV15114

Identifier Type: -

Identifier Source: secondary_id

229N

Identifier Type: -

Identifier Source: org_study_id